DC-Lineate SE-091

GUDID 00628063400485

SEKISUI DIAGNOSTICS, LLC

Unsaturated iron binding capacity (UIBC) IVD, calibrator
Primary Device ID00628063400485
NIH Device Record Keyaee38051-f692-4ca7-aac2-4cc0f7be680c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDC-Lineate
Version Model NumberSE-091
Catalog NumberSE-091
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628063400485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JISCALIBRATOR, PRIMARY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

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00628063401321 - Alinity c Acetaminophen Calibrator2023-05-16
10742860100397 - OSOM ULTRA PLUS FLU A&B Test 2022-06-10
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063400003 - Carbon Dioxide L3K2019-10-21
00628063400287 - CARBON DIOXIDE L3K Assay2019-10-21

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